The FDA named two European drug manufacturers—Delarange Cosmetics & Healthcare of the Netherlands and Wallace Cameron of the U.K.–in separate warning letters, citing poor quality control, filthy equipment and failure to register with the agency.
In the case of Delarange, the FDA said in a warning letter recently posted on its website that during an inspection that ran from May 30 to June 3 of its facility in Zeewolde, it found the firm wasn’t testing its finished products and wasn’t using a quality control unit to review and approve the release of its drugs.
Additionally, inspectors found Delarange wasn’t properly cleaning the equipment, which could result in product contamination.
As for Wallace Cameron, located in Wishaw, Scotland, the regulatory agency scolded the firm for failing to register and list its products with the FDA.
“Our records indicate that you have not registered your establishment for 2016, but have continued to manufacture, prepare, propagate, compound, or process drugs that were not listed but being imported or offered for import into the United States during this time,” the agency says in its warning.
The drug manufactured at Wallace Cameron wasn’t mentioned by the agency.
by Joseph Keenan | Oct 13, 2016